Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers

Last updated: March 22, 2024
Sponsor: Tarsus Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

4

Condition

Blepharitis

Treatment

Lotilaner ophthalmic solution, 0.25%

Vehicle control

Clinical Study ID

NCT06182358
TRS-023
  • Ages 18-70
  • All Genders

Study Summary

To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be willing to sign the informed consent form and is deemed capable of complying withthe requirements of the study protocol
  • Must meet the following criteria in at least one eye: Have more than 10 eyelashes (Grade 2 or higher) with collarettes on the upper or lower eyelid; have at least Grade 1 erythema of the lower eyelid; and have a total meibomian gland secretion score ≥ 12but ≤ 32 AND have a minimum of 6 expressible glands for the 15 glands evaluated on thelower eyelid
  • Currently wearing soft contact lenses on both eyes an average of at least 2 days perweek with an average minimum wearing time of 6 hours each day over the past 3 monthsand is able and willing to continue to wear contact lenses during the study

Exclusion

Exclusion Criteria:

  • Use of artificial tears or rewetting drops within 24 hours of the Screening visit orunwilling to forego the use of this treatment during the study
  • Prescription AND systemic, drug delivery implant, ocular topical, or topical:antibacterial, anti-parasitic, or anti-inflammatory corticosteroid treatment within 14days of the Screening or Day 1 visits
  • Use of TYRVAYA™ Nasal Spray (varenicline solution, Oyster Point Pharma) within 14 daysof the Screening visit or unwilling to forego the use of this treatment during thestudy
  • Use of XDEMVY™ (lotilaner ophthalmic solution) 0.25%, Tarsus Pharmaceuticals, Inc.,within 12 months of the Screening visit
  • Treatment for blepharitis (e.g., tea tree oil-based products, hypochlorous acid-basedproducts, commercial eyelid foams, eyelid wipes, lid scrubs, etc.) within 14 days ofthe Screening visit or unwilling to forego the use of these treatments during thestudy
  • Use of artificial eyelashes or eyelash extensions at the Screening visit if they limitaccurate eyelid margin assessment
  • Currently pregnant or lactating

Study Design

Total Participants: 166
Treatment Group(s): 2
Primary Treatment: Lotilaner ophthalmic solution, 0.25%
Phase: 4
Study Start date:
December 27, 2023
Estimated Completion Date:
December 31, 2024

Study Description

This Phase 4 study is a prospective, multicenter, randomized, vehicle-controlled, double-masked, two-arm, parallel treatment clinical trial of participants who have Demodex blepharitis and are current daily wear soft contact lenses wearers. The primary outcome measure is the reduction of collarettes at Day 43. The secondary outcome measures are the reduction of eyelid margin erythema at Day 43; subject-reported comfortable contact lens daily wear time; and total contact lens wear time. Safety will be determined by assessing adverse effects related to study drug administration as well as evaluating any clinically significant changes from baseline in visual acuity and slit lamp biomicroscopy findings.

Connect with a study center

  • Site

    Cave Creek, Arizona 85331
    United States

    Active - Recruiting

  • Site

    Long Beach, California 90805
    United States

    Active - Recruiting

  • Vision Institute

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Site

    Delray Beach, Florida 33484
    United States

    Active - Recruiting

  • Site

    Indianapolis, Indiana 46240
    United States

    Active - Recruiting

  • Site

    Pittsburg, Kansas 66762
    United States

    Active - Recruiting

  • Site

    Louisville, Kentucky 40206
    United States

    Active - Recruiting

  • Site

    Edina, Minnesota 55436
    United States

    Active - Recruiting

  • Site

    Shelby, North Carolina 28150
    United States

    Active - Recruiting

  • Site

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

  • Site

    Powell, Ohio 43065
    United States

    Active - Recruiting

  • Site

    Cranberry Township, Pennsylvania 16066
    United States

    Active - Recruiting

  • Site

    Memphis, Tennessee 38104
    United States

    Active - Recruiting

  • Site

    Houston, Texas 77005
    United States

    Active - Recruiting

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